The present invention relates generally to dietary supplements, and, more particularly, to a blend of creatine, ginseng, and astragalus, and, optionally, glutamine for increasing energy, strength, and immune function.
As we age, our bodies undergo a variety of changes. We often lose strength and energy due to declines in hormone levels and a more sedentary lifestyle. These changes can frequently interact with each other to produce compounding effects. For example, the loss in muscle strength increases the likelihood of falls and broken bones, which can lead to further declines in physical activity and strength. While some of these declines in strength and energy levels are inevitable, they can also result from nutritional deficiencies and changes in lifestyle patterns. This is partly responsible for the greater utilization of medical resources by senior citizens and consequent impacts on Medicare expenditures.
One muscle-building substance which does not typically exhibit any significant side effects is creatine, which is derived from reactions involving the amino acids arginine, glycine, and methionine: 
Creatine is a nutrient that increases protein synthesis and intra-cellular water levels within the muscle fibers, resulting in greater strength and muscle mass. This boosts daily caloric expenditure, which will lower body-fat stores if food intake is unchanged. A discussion of the benefits may be found in a book by Ray Sahelian and Dave Tuttle, entitled Creatine: Nature""s Muscle Builder, Avery Publishing Group (1997).
Given the well-established, beneficial effects of creatine for adding strength and power, building lean muscle mass, boosting sports endurance, and helping to reduce body fat, and the rare incidence of associated side effects, it would be desirable to provide creatine in a dietary supplement improved over that already commercially available. Such a dietary supplement should enhance the general energy-boosting and muscular strength-increasing qualities offered by creatine without introducing any harmful side effects. It should be inexpensively manufactured, and comply with all applicable government regulations.
U.S. Pat. No. 5,308,627, entitled xe2x80x9cNutritional Supplement for Optimizing Cellular Healthxe2x80x9d and issued to A. J. Umbdenstock, Jr., on May 3, 1994, is directed to a nutritional supplement, functioning as a food for special dietary use, to enhance diets and assist persons recovering from addiction to health-damaging substances. The nutritional supplement consists of a mixture of nutrients, specifically, minerals, vitamins, anti-oxidants, amino acids, herbs, and/or other nutrients, which are said to cooperate synergistically in enhancing cellular metabolic pathways and to assist in normalization of cellular function and optimization of cellular health. In one embodiment, the supplement comprises at least one amino acid and at least one herbal antispasmodic substance.
While the ""627 patent teaches the use of an xe2x80x9cherbal antispasmodic substancexe2x80x9d in the treatment of alcoholism (Col. 3, lines 52-65), there is no evidence that ginseng and astragalus (two herbs employed in the present invention), despite centuries of use as individual herbs, have antispasmodic properties. Nor is there any indication that combining aqueous extracts of these herbs with creatine, and, optionally, glutamine, also employed in the practice of the present invention, would produce such antispasmodic properties. Ginseng and astragalus simply are not known to reduce spasms, although they are well-known for many other benefits.
Moreover, Umbdenstock teaches a supplement with at least one enzyme-activating substance and at least one enzyme cofactor. This enzyme-activating substance is a mineral (Col. 6, line 18-19), while the enzyme cofactor is a vitamin (Col. 6, 38-39). There are no vitamins or minerals in the present invention.
Further, while glutamine is included in the dietary supplement taught by the ""627 patent (Col. 10, line 12), its function is to permit degradation of harmful NH4 to NH3 for removal in the urine of alcoholics. The present application teaches the use of glutamine to promote the release of growth hormone and to provide a source of energy for the cells of the immune system and the mucosal cells of the intestinal tract in combination with creatine and herbal extracts that are not taught in the ""627 patent. Therefore, this patent does not teach art relevant to the present invention.
Further, Umbdenstock proposes the use of an amino acid that xe2x80x9cproduces an enzyme that acts as a catalyst for the normalized cellular chemical reactionxe2x80x9d (Col. 3, lines 54-56). To the best of the present inventor""s knowledge, creatine, which is an amino acid, does not produce such an enzyme. Rather, creatine provides an additional substrate for increased resynthesis of ATP by boosting levels of creatine phosphate; see, e.g., Creatine, supra, pp. 75-82. While the enzyme creatine kinase does facilitate this reaction, the present inventor does not know of any evidence that supplemental creatine increases levels of creatine kinase, nor is there any reason to suppose that this should occur, inasmuch as creatine kinase is not used up in the reaction.
U.S. Pat. No. 4,708,949, entitled xe2x80x9cTherapeutic Composition from Plant Extractsxe2x80x9d and issued to Y. Liu on Nov. 24, 1987, discloses a therapeutic composition composed of four plant extracts: ginsenoside, tetramethyl pyrazine, astragalan, and atractylol. These four ingredients are said to be highly effective in treating cerebral vascular disease and the sequelae thereof, whereas the present invention teaches a method for enhancing energy, strength and immune function.
Moreover, the composition taught by the ""949 patent is comprised of specific plant chemicals, not extracts of whole herbs. While ginsenoside is contained in ginseng and astragalan is found in astragalus, there are many other active chemicals in each of these herbs. Although ginsenoside content is used as a quality marker in the present invention, it is not the only component with therapeutic properties. In fact, a polysaccharide marker is included in the preferred composition of the present invention so that a range of plant chemicals will be included instead of simply ginsenoside. Tetramethyl pyrazine and atractylol, the other two extracts in the ""949 patent, are not found in the present invention. Therefore, this patent does not teach art relevant to the present invention.
Further, Liu""s extraction process involves ethanol. The preferred composition of the present invention utilizes only aqueous extraction to ensure that older individuals with possibly compromised immune systems do not consume a dietary supplement with solvent residues.
Thus, a need remains for a creatine-based supplement for increasing energy, strength, and immune function.
In accordance with the present invention, a dietary supplement is provided that comprises creatine combined with ginseng and astragalus and, optionally, glutamine. The present supplement therefore enhances the general energy boost and muscular strength increase achieved from the consumption of creatine alone, while also increasing immune function. The components are provided together in at least one capsule.
More particularly, the dietary supplement of the present invention will help mature individuals overcome the problems noted above by providing the specified nutrients that work together to boost energy and enhance muscle growth. The dietary supplement will also increase the strength and sense of vitality of such mature individuals.
Reference is now made in detail to a specific embodiment of the present invention, which illustrates the best mode presently contemplated by the inventor for practicing the invention. Alternative embodiments are also briefly described as applicable.
The dietary supplement of the invention comprises creatine, ginseng, and astragalus, optionally combined with glutamine. The dietary supplement composition is preferably put into a capsule using known technology. The total daily dosage for an adult is 3 to 6 capsules per day. The capsules are preferably consumed with two or three meals to provide a relatively even intake of the nutrients in the composition throughout the day. However, the dosage regimen is flexible as long as the total daily dosage is achieved.
The creatine employed in the practice of the present invention is of a pharmaceutical grade that is commercially available from various manufacturing sources. It is preferably in the form of creatine monohydrate. However, other creatine derivatives, such as creatine citrate and creatine pyruvate, may also be employed in the practice of the invention.
In addition to creatine, the present dietary supplement contains two other complementary herbal extracts, ginseng and astragalus, and, optionally, an amino acid, glutamine, to provide benefits that enhance the nutritional quality of creatine alone. Thus, there are two possible combinations:
creatine, ginseng, and astragalus, and
creatine, ginseng, astragalus, and glutamine.
Each capsule of the invention preferably contains the following ingredients, within the following ranges: (a) about 250 to 1500 mg of creatine monohydrate; (b) about 100 to 600 mg of ginseng (c) about 100 to 600 mg of astragalus; and, if employed, (d) about 100 to 600 mg of L-glutamine.
Creatine is a naturally occurring nutrient. It is found in the skeletal and cardiac muscles of all animals, including man. While it would be theoretically possible to get enough creatine to increase strength levels from eating large quantities of meat, the cholesterol and fat content of these foods makes this highly inappropriate. The preferred alternative is to use creatine monohydrate, a manufactured nutrient that is both inexpensive and highly effective. Alternatively, the creatine may be in the form of creatine citrate and/or creatine pyruvate and/or creatine chelates, such as creatine magnesium chelate, alone or in combination with creatine monohydrate.
More than 50 studies have analyzed the effects of creatine monohydrate during the 1990s. These studies have found that creatine increases muscular strength, peak torque production and mean power output. It does this by providing more raw material for the resynthesis of ATP, or adenosine triphosphate. This allows the muscles to remain within the ATP-CP energy pathway longer, and lengthens the time before muscular contraction ceases due to lactic-acid buildup. There is also an increase in lean muscle mass and protein synthesis due to a creatine-induced rise in intracellular (but not subcutaneous) water levels. While these changes are maximized with exercise, they also occur in sedentary individuals. A 1996 study by Hultman with individuals told to avoid physical exercise found that a daily dosage of 3 grams raised intracellular creatine concentrations to effective levels; see, e.g., E. Hultman et al, xe2x80x9cMuscle creatine loading in menxe2x80x9d, Journal of Applied Physiology, Vol. 81(1), pp. 232-237 (1996).
The transport mechanism used to shuttle creatine into the muscle cells involves insulin. The required spike in insulin levels is produced by the carbohydrates in a regular meal (40 to 50 grams), hence the recommendation that the dietary supplement be taken with meals. Due to its ability to increase lean mass, creatine also boosts the body""s daily caloric expenditure. (Each pound of muscle requires approximately 20 calories per day to xe2x80x9clivexe2x80x9d). If use of the dietary supplement of the invention increases lean mass by 5 pounds, this boost in caloric requirements would result in a loss of a pound of body fat per month if food intake is unchanged.
Preferably, creatine monohydrate that has been manufactured in accordance with the teachings of U.S. Pat. No. 5,719,319 is employed in the practice of the present invention. Alternatively, other technology that produces equivalent or lower impurity levels may be employed.
Preferably, Panax ginseng is employed as the preponderant herb. However, other forms of ginseng may alternatively be used. Such other forms include, but are not limited to, Panax quinquefolius, Panax notoginseng, Eleutherococcus senticosus, and Acanthopanax senticosus. The ginseng used in the formulation of the invention should be a lyophilized or air-dried aqueous extract obtained from roots with a total saponin content of not less than 4.0 percent.
Ginseng has been revered in China as the King of Herbs for centuries. It helps to replenish the qi, or life force, of the body through a number of mechanisms. Ginseng is an adaptogen, which means that it works with the body to help restore balance. Chinese practitioners use it as a tonic to increase physical strength and energy and promote the proper functioning of the body""s organs. They also use it to treat fatigue. Ginseng builds stamina and endurance by enhancing the body""s ability to adapt to stress. It was used extensively in former Soviet countries as a way to boost strength and athletic performance.
The dietary supplement of the present invention preferably contains primarily Chinese or Korean ginseng, which is recommended for its warmer qualities. Panax ginseng has additional properties that will be of interest to mature individuals. It strengthens the heart muscle and stimulates the immune system. It also increases cerebral circulation, which enhances memory, alertness and other cognitive functions. Some of the active principles in the herb, known as ginsenosides, have antioxidant properties as well. These benefits have been verified in over 3,000 studies conducted in the last 50 years.
The preferred composition contains lesser amounts of Panax quinquefolius, also known as American ginseng. This herb has stress-reducing qualities that help to balance the warmer properties of Panax ginseng. It also promotes proper functioning of the immune system.
Preferably, lyophilized or air-dried aqueous extracts of Panax ginseng root and Panax quinquefolius root are employed in the practice of the present invention in a ratio of 60% Panax ginseng and 40% Panax quinquefolius. Both herbal extracts preferably have a ginsenoside content of not less than 10% as measured by ultraviolet visible light spectrophotometry absorbance (UV) and a polysaccharide content of not less than 10% as measured by UV. Further, the extracts preferably have levels of quintozene and other pesticides and heavy metals that are below U.S. Environmental Protection Agency detection levels.
Astragalus is employed in the form of Astragalus membranaceous and should be the lyophilized or air-dried aqueous extract of the root of the plant. Astragalus works with ginseng to build energy levels, heighten immune-system activity, and increase the body""s ability to adapt to stress.
While largely unknown in Western countries, astragalus has been used for thousands of years in traditional Chinese medicine as part of the Fu-Zheng therapy to enhance natural defense mechanisms. It is sometimes combined with ginseng in tonics because of its interactive actions with that herb. Astragalus is particularly effective in the sphere of influence of the spleen. The Chinese consider the spleen to be the middle burner, where the body""s energy builds. Astragalus is able to supplement this energy when it is deficient, making it an excellent long-term energy builder. It has been used by Chinese herbalists to treat every type of fatigue and exhaustion.
The herb is also said to stabilize the exterior of the body and increase its resistance to disease by increasing the circulation of wei qi, or protective life force, on the body""s surface. This enhances immune function and boosts the body""s ability to adapt to stress. Astragalus stimulates the proliferation of stem cells, macrophages and lymphocytes as well, helping the immune system to hold off invading organisms. It has even been shown to increase the life span of human cells in culture.
Preferably, lyophilized or air-dried aqueous extracts of Astragalus membranaceous with a total flavonoid content of not less than 1% as measured by UV and a polysaccharide content of not less than 20% as measured by UV are employed in the practice of the present invention. Further, the extracts preferably have levels of pesticides and heavy metals that are below U.S. Environmental Protection Agency detection levels.
Glutamine is an amino acid that promotes the release of growth hormone, which also increases strength and lean muscle mass. Glutamine also promotes better assimilation of nutrients and speeds up recuperation. Preferably, the levo form, L-glutamine, is employed in the practice of the invention.
Glutamine is an important amino acid for mature individuals. It boosts the secretion of growth hormone from the pituitary gland, which can help offset the reductions in this vital hormone that occur with aging. Growth hormone has a major role in the growth and retention of muscle due to its ability to promote cell division and proliferation in the body. It increases the amount of amino acids transported across the cell membrane, which provides the raw material needed for more protein synthesis. This gives the formula another mechanism to increase strength and muscle mass. Growth hormone even boosts the level of free fatty acids in the blood, resulting in greater use of fats as an energy source and the sparing of available proteins and carbohydrates. By raising the body""s energy expenditure at rest, it works beneficially with creatine to help reduce body-fat levels.
Glutamine plays a vital role in the immune system. Many of the cells of this system use glutamine for fuel. Studies have shown that supplemental glutamine speeds recuperation and helps people regain the strength they lose after an illness. Glutamine also provides fuel for the mucosal cells of the intestines, which can improve the assimilation of nutrients. It regulates the body""s acid-base balance as well. This neutralizes the high levels of lactic acid that build up during exercise.
In a preferred composition of the dietary supplement of the present invention, the ratio of creatine monohydrate relative to the other three ingredients is approximately 3:1:1:1, and is represented by the following formulation, in which the capsule or capsules contain about:
A suggested dosage is one or two capsules with breakfast, lunch and dinner, or a total of three to six capsules per day.
A more preferred composition is based on the following ratios to realize full maximum effectiveness of the formulation:
The foregoing ratios result in the following ratios for the herbal extract:
A maximum variation of plus or minus 10% in the foregoing ratios is permitted for the more preferred composition. Three examples of acceptable combinations are as follows:
In the more preferred composition of the present invention, the three herbs are mixed in the specified ratios prior to initiation of the extraction process. This maximizes the interactive properties of the finished extract.
No adverse side effects are reported in the literature at the dosages indicated herein for the listed components.
Older individuals with decreased muscle mass and energy levels will benefit from the dietary supplement of the present invention. Since creatine and L-glutamine boost strength and protein synthesis, they both help to reduce the muscle wasting process that can occur with disease and the aging process. The interactive effects of ginseng and astragalus will enhance immune function, while the interactive effects of creatine, ginseng and astragalus will help to maintain and increase energy levels in these individuals. Being more muscular and energetic can also lead to an improved sense of well-being, resulting in older individuals who look and feel years younger. Stronger muscles will lead to fewer falls and bone fractures, too. Finally, use of the dietary supplement by older individuals may motivate users to continue exercising, which itself is known to lead to stronger bones and a healthier heart.